159
Participants
Start Date
March 1, 2000
Primary Completion Date
January 30, 2005
Study Completion Date
March 30, 2010
Thalidomide
Thalidomide 200 mg given orally every evening at 9pm. Treatment may continue indefinitely provided that there are no dose-limiting toxicity.
leuprolide acetate
Injections of leuprolide once a month for six months.
goserelin
Injections of Goserelin once a month for six months.
Placebo
Patients will receive the placebo if they initially received thalidomide. The starting dose of placebo 200 mg (four capsules of 100-50 mg capsules) orally once daily at bedtime.
University of Pittsburgh, Pittsburgh
National Institutes of Health, Clinical Center, 9000 Rockville Pike, Bethesda
Naval Medical Center, Portsmouth, Portsmouth
Holy Cross Hospital, Fort Lauderdale, Fort Lauderdale
Wayne State University Hutzel Hospital, Detroit
University of Minnesota, Minneapolis
University of Washington, Seattle
Louisiana State University, New Orleans
Columbia University, New York
Holy Cross Hospital, Fort Lauderdale
UNKNOWN
Louisiana State University Health Sciences Center in New Orleans
OTHER
Wayne State University
OTHER
University of Minnesota
OTHER
Columbia University
OTHER
University of Pittsburgh
OTHER
United States Naval Medical Center, Portsmouth
FED
University of Washington
OTHER
National Cancer Institute (NCI)
NIH